IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La— 510(k) K253817

Name: FDA 510(k) clearance K253817
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Substantially Equivalent

Immunodiagnostics Systems Limited

FDA 510(k) clearance K253817 for IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La, Substantially Equivalent on 2026-08-21. Applicant: Immunodiagnostics Systems Limited. Device class: 2.

Clearance details

Applicant: Immunodiagnostics Systems Limited
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2025-11-28
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

Download summary PDF View on FDA.gov ↗

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